Health care providers (“providers”), including hospitals, clinics and doctor's offices, routinely order laboratory tests for patients. These tests include blood analyses, pathological analyses, radiological analyses and, more recently, genetic and genomic analyses. The tests are performed by third-party laboratories, many of which specialize in the types of analyses they perform. Laboratories that provide genetic or genomic analysis are particularly likely to perform highly specialized, and sometimes proprietary, analyses. Thus, a provider may use many laboratories, particularly genetic or genomic laboratories, to meet all its analytical needs, and a laboratory, particularly a genetic or genomic laboratory, may perform analyses for many different providers.
Orders for these tests are often sent on paper, typically via facsimile transmission (“fax”) from the providers to the laboratories. The laboratories then perform the tests and send results back to the providers, typically also via fax. The results may include reports, which are typically narratives, and/or results, which are typically data. In some cases, a test and interpretation of test results are performed by different organizations. For simplicity, the term “laboratory” is used herein to mean an organization that performs tests and/or analyzes or interprets test results.
Some providers maintain electronic medical records (EMRs), which contain patient data. However, laboratory analyses received in paper form are not easily added to an EMR. Adding information from paper-based analyses to an EMR is costly and error-prone.
Some laboratories are equipped to receive orders electronically directly from providers, and some laboratories are equipped to send analyses electronically directly to providers. Similarly, some providers are equipped to send orders and receive analyses electronically to and from laboratories. However, even many electronic messages are not sufficiently structured to facilitate automatically adding message information to an EMR in a manner that makes the information useful for clinical support.
Furthermore, a variety of message syntaxes and schemas are used by providers and laboratories to convey orders and analyses. Collectively, syntax and schema determine two parts of a message “form,” as discussed in detail below. Each provider and each laboratory may use a different message form. Sometimes the message form further depends on an application or device (collectively hereinafter “application”) used by a provider to request an analysis or on an application used by a laboratory to perform a requested analysis. Although many providers and laboratories use standards-based message protocols, such as Health Level Seven (HL7), differences exist among the message forms, even among organizations that use a given protocol, due to differences in how these organizations interpret the protocol, differences among various versions of a given protocol, individual organizations' data needs, how the providers structure their respective EMR systems, etc.
In addition to syntactic and schematic differences, other details of a message's form often depend on the sender of the message. For example, analyses often contain diagnostic codes. While many of these codes are standardized, others are not. In the rapidly expanding genetics or genomics sphere, codes for newly-discovered genetic variations are created, and the meanings of existing codes are changed, at a rapid rate. These additions and changes are not always made in a standardized manner or universally adopted. Thus, messages from a variety of laboratories are likely to be generated using a variety of proprietary vocabularies, leading to semantic differences among laboratories and between laboratories and providers.
The syntactic, schematic and semantic differences among laboratories and providers impede establishing electronic communications capabilities between the laboratories and the providers. To establish an electronic messaging capability between a provider and a laboratory, the parties must negotiate a form for messages each party sends to the other party. Often, the forms used between a provider and a laboratory are asymmetric, i.e., the provider sends messages in one form, and the laboratory sends messages in a different form. In many cases, the provider, the laboratory or both parties must modify their systems to accommodate the form used to send messages to, and receive messages from, the other party. Consequently, a custom built software interface is often required for one or both parties that wish to communicate electronically with each other.
Although some laboratories and some providers have developed some of these interfaces, each interface is expensive and time-consuming to construct and maintain. The cost to establish even a fraction of the number of interfaces a laboratory or provider would need to electronically communicate with all its peers is beyond the reach of most laboratories and providers.
Furthermore, not all applications are capable of sending or receiving a full set of electronic message types. For example, some versions of HL7 define four message types that, collectively, provide a “hand-shake” sequence. A “Results Complete” message is sent by a laboratory with a completed analysis. A provider may respond with a “Results Confirm Response” message to acknowledge receiving a Results Complete message. Alternatively, the provider may respond with a “Results Rejected Response” message. For example, this Results Rejected Response message may be sent if the Results Complete message from the laboratory is in an unacceptable form. In addition, after having sent a Results Complete message, a laboratory may send a “Results Corrected” message with updated or corrected analyses. Not all applications are capable of sending some or all of these messages. Thus, automated equipment in one party's location (such as in a laboratory) may not be fully taken advantage of by less capable equipment in the other party's location.
Thus, limitations exist in the abilities of laboratories and providers to electronically communicate orders and laboratory results, because not all laboratories and providers are equipped to communicate electronically, and even many of those that are so equipped would require prohibitively expensive interfaces to accommodate syntactic, schematic and semantic differences in messages from or to all their peers. In addition, the pace and volume of new discoveries in genetics and genomics is increasing the number of these differences and the complexity of creating and maintaining messaging interfaces.